How do I structure logistic processes in preparation for outsourcing of cellular therapy manufacturing?

As cell and gene therapies (CGT) assume center stage in early-phase clinical trials for several acute and chronic diseases, there is heightened interest in the standardization and automation of manufacturing processes in preparation for commercialization. Toward this goal, a hybrid and oftentimes geographically separated model comprising regional cell procurement and infusion facilities and a centralized cell manufacturing unit is gaining traction in the field. Although CGT processing facilities in academic institutions are not involved directly in the manufacturing of these therapies, they must be prepared to collaborate with commercial or contract manufacturing organizations (CMOs) and be ready to address several supply-chain challenges that have emerged for autologous and allogeneic CGT.

KEL6 and KEL7 genotyping with sequence-specific primers.

Background: Although antibodies to Js(a) and Js(b) are clinically significant, reagent-quality anti-Js(a) and anti-Js(b) are not readily available. A sequence-specific primer-polymerase chain reaction (SSP-PCR) genotyping assay was tested that makes use of two single-nucleotide polymorphisms (SNPs) at positions 1910 and 2019 of KEL. These SNPs distinguish the gene encoding Js(a), KEL6; and Js(b), KEL7.